Kornimate/medical-research-clean huggingface dataset:
positive adjustment coping intervention

Conditions: Infertility/Sterility

Summary: involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. aim of this rct study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.

about 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in germany, which is experienced as "roller coaster of emotions". the positive effect of "face-to-face" counseling for couples with a desire for children has been proven. however, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling. in this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design. for this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the screenivf questionaire. the screenivf will be completed paper-pencil before the intervention and online after the intervention. in the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.in addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques. sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported. no adverse effects or other risks are expected for the study participants.

Eligibility criteria:
inclusion criteria: all couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the department of gynecologic endocrinology and fertility disorders at heidelberg university women's hospital, which have * agreed to participate in the study * indicated their mobile phone number * sufficient knowledge of german language. if one partner is refusing to participate, the other person may be admitted as an individual. exclusion criteria: * denial of participation * non-existent smartphone * insufficient knowledge of german language

Keywords: assisted reproductive technology embryo transfer online intervention rct
effect of aldosterone on energy starvation in heart failure

Conditions: Heart Failure; Nonischemic Dilated Cardiomyopathy

Summary: we plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (nidcm) (heart failure with reduced heart pump function due to causes other than heart attack). we will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).

preliminary results showed reduced subendocardial myocardial perfusion reserve in nidcm compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.

Eligibility criteria:
inclusion criteria: * 18 years or older * nonischemic dilated cardiomyopathy * left ventricular ejection fraction 35% or less * stable heart failure symptoms * able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium * able to tolerate treatment with spironolactone exclusion criteria: * serum potassium \>5.0 * serum creatinine \>2.5 * contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.

Keywords: heart failure positron emission tomography magnetic resonance imaging myocardial energetics myocardial perfusion
vibro-acoustography imaging in finding breast microcalcifications and lesions in women

Conditions: Breast Cancer

Summary: rationale: new diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of finding microcalcifications and lesions in the breast. purpose: this clinical trial is studying how well vibro-acoustography imaging works in finding breast microcalcifications and lesions in women.

objectives: * to further develop a new method of in vivo imaging of the breast using vibro-acoustography (va) imaging. * to demonstrate and evaluate the capability of va imaging in detecting microcalcifications and lesions inside the human breast. outline: participants undergo vibro-acoustography (va) imaging of the breast using ultrasonography over 90 minutes. participants may also undergo further imaging using clinical ultrasonography.

Eligibility criteria:
disease characteristics: * meets one of the following criteria: * healthy participant * proven microcalcifications and/or lesions in the breast * hormone status not specified patient characteristics: * female * menopausal status not specified * not pregnant or nursing * no condition that does not allow proper use of study imaging devices prior concurrent therapy: * not specified

Keywords: breast cancer
reduced manipulation of the aorta and neurobehavioral outcome trial

Conditions: Coronary Disease

Summary: the purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.

patients who have coronary artery bypass graft (cabg) surgery must have their aorta (the large blood vessel that is attached to the heart) clamped with an instrument. there are two basic ways of manipulating the aorta during surgery. one way is to place a single clamp across the aorta. the other way is to place more than one clamp on the aorta in several places. both methods are used, but it is not known if one way is better than the other. the purpose of this study is to compare the two methods of clamping to see if one way is better than the other, and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during cabg surgery and have a lower incidence of neurobehavioral problems following surgery. microemboli are tiny fat particles that enter the bloodstream during surgery, circulate to the brain, and block tiny blood vessels, causing brain deficits. participants in this trial will be randomly classified into one of two groups: the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection, and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection. neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests.

Eligibility criteria:
* participants must be english-speaking patients, * 50 years of age or older, and * undergoing elective cabg surgery. * participants of both genders and all races are eligible.

Keywords: coronary artery bypass graft surgery cabg surgery neurobehavioral impairment aorta clamping aorta manipulation microemboli
an integrative multi-omic characterization of head and neck carcinogenesis, progression and recurrence

Conditions: Head and Neck Carcinoma

Summary: this study evaluates the cell and biomarkers associated with the aggressive behavior of cancer.

primary objective: i. high-resolution single-cell profiling of cancer-associated fibroblasts (cafs) in human papillomavirus (hpv)+ oropharyngeal squamous cell carcinoma (opscc) and metastatic lymph nodes. outline: this is an observational study. patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * diagnosis/disease status: new diagnosis of head and neck cancer * allowable type and amount of prior therapy: no prior treatment * age ≥ 18 years. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * patients who have had treatment of head and neck cancer
comparison of the pharmacodynamics and pharmacokinetics of insulin aspart and human insulin in elderly people with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * duration of diabetes for at least 12 months * current treatment with human insulin or insulin analogues for at least 6 months * bmi equal to or below 35 kg/m2 * hba1c equal to or greater than 10.0 % * no clinically significant cardiovascular event as judged by the investigator within the last 6 months prior to the study exclusion criteria: * history of any illness that, in the opinion of the investigator might confound the results of the study or pose additional risk in administering the trial products to the subject * current treatment with systemic corticosteroids * any positive reaction of drug of abuse or alcohol screen * cardiac problems defined as: decompensated heart failure and/or angina pectoris * uncontrolled treated/untreated hypertension as judged by the investigator or blood pressure \> 180 mm hg systolic and/or \> 110 mm hg diastolic * known or suspected allergy to trial product or related products * blood donation of more than 500 ml within the last 12 weeks * the receipt of any investigational drug within 4 weeks prior to this trial
enhancing anaesthetic success in mandibular molars with symptomatic irreversible pulpitis: a comparative randomized controlled trial

Conditions: Pulpitis - Irreversible

Summary: the goal of this clinical trial is to assess the effect of * preoperative intraligamentary corticosteroids injection * cryotherapy which is cold application on : * hard tooth structure ( crown of the tooth ) * soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. the main question it aims to answer are: • does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication. participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.


Eligibility criteria:
inclusion criteria: * participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study. * having a mandibular molar tooth diagnosed with symptomatic irreversible pulpitis (hot tooth - vital pulp, intermittent or continuous sharp pain that lasts longer after removal of the stimulus). exclusion criteria: * presence of any systemic disease or allergic reactions. * vulnerable group; prisoners, pregnant females, mentally ill, etc... * the presence of a periapical radiolucency. * teeth with open apices. * a previous root canal treatment. * sinus tracts. * local gum swelling around the affected tooth. * severe periodontal disease . * presence of periodontal pockets \>3 mm in the affected tooth. * absence of bleeding in the pulp chamber on access cavity preparation. * patients with doubted diagnosis due to multiple carious teeth.

Keywords: dexamethasone intraligamentary cryotherapy
telipro health program - active with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: in a randomized-controlled trial the hypothesis should be tested that the telemedical lifestyle intervention program telipro could significantly improve hba1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (t2dm) patients.

t2dm patients, assured at the health insurance aok rhineland / hamburg will be randomized into two parallel groups. in addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. the telipro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching. participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. in addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the aok rhineland / hamburg. patient preference for type 2 diabetes intervention will be recorded using discrete choice experiment (dce) questionnaires at the beginning of the program and at the end of the intervention. as part of the development and validation of the dce, focus groups are used to determine the dce attributes. in addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * body mass index of et least 27 kg/m2 exclusion criteria: * acute infections * chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate \<30 ml/min/1.73 m2) * acute chemotherapy or chronic cortisol treatment * smoking cessation for \<3 months and/or planned smoking cessation during study * pregnancy or breast-feeding

Keywords: diabetes mellitus, type 2
study of oral papillomavirus in teens and twenties

Conditions: STD

Summary: recently human papillomavirus (hpv) has been recognized to cause some oropharyngeal (tonsil) cancer. but very little is known about oral hpv infection and risk factors. this study will evaluate how common oral hpv infection is, what sexual behaviors are associated with risk for infection, and how long infections tend to last.

18-25 year old individuals are being recruited from std clinics in baltimore county and followed every three months for this study.

Eligibility criteria:
inclusion criteria: * age 18 -26 years exclusion criteria: * never received hpv vaccine (gardasil or cervarix)

Keywords: hpv oral cancer young adults
protocol of multi-domain attention training

Conditions: Mild Cognitive Impairment

Summary: this study sought to investigate the changes in attention in older adults with mild cognitive impairment after multi-domain attention training .

this double-blind randomized controlled study has a 2-arm parallel group design. all subjects will be randomized by the block randomization, into intervention group (multi-domain attention training, mat), or active control group (passive information activities, pia). training sessions of the mat group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). the training of pia group is the same as mat group. the investigators constructed a rigorous mat program adhering to the consolidated standards of reporting trials (consort) reporting guidelines. the investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the mat program.

Eligibility criteria:
inclusion criteria: * participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant * objective memory impairment on neuropsychological tests of memory 1.5 sd or more below age/education norms * clinical neurologic examination by the mini-mental state examination (mmse) score of 24 or higher * no impairment in personal activities of daily living (p-adl) as determined by clinical interview with participant and family exclusion criteria: * the clinical diagnosis of dementia was based on the dsm-iv-tr * active in another cognitive or memory-related training in the past year * comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment * a diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible * severe losses in vision, hearing, or communicative ability
insights from the retina on cerebral microvascular dysfunction in haemorrhagic stroke

Conditions: Intracerebral Hemorrhage

Summary: fundoscopy, optical coherence tomography (oct) and oct-angiography (octa) are established examinations and bear minimal risks. the recognition of retinal microvascular signs will enhance the pathophysiological understanding of the vasculopathy in patients with intracerebral haemorrhage (ich) and aneurysmatic subarachnoid hemorrhage (asah) and might serve as prognostic and diagnostic indicators.

the purpose of the study is to * to evaluate the feasibility of fundoscopy, oct and octa imaging in the environment of a neurocritical care unit (nccu) * to detect, quantify and associate microvascular changes in the retina with signs of micro-vessel disease in ich and dci in asah

Eligibility criteria:
inclusion criteria: * all groups * primary ich or asah with symptoms onset \< 3 days * 18 to unlimited years of age * signed informed consent obtained from legal representative or patient ich group * primary ich localized either in basal ganglia, thalamus, pons or cerebellum asah group * ruptured aneurysm visualized in contrast-enhanced computed tomography (angio-ct), mri or cerebral angiography control group * stroke due to perimesencepahlic subarachnoid hemorrhage, arteriovenous malformation or isolated traumatic brain injury exclusion criteria: * all groups * cerebral amyloid angiopathy or other neurodegenerative disease * history of migraine with aura or ischemic stroke * contraindication for pupil dilation (intracranial hypertension, allergy against mydriatics, angle closure glaucoma) * any pre-existing or manifest ocular condition affecting either the integrity of retinal vessels, transparency of optical media or the risk of acute angle closure glaucoma * concomitant instable critical illness (e.g. sepsis, multi-organ failure) * intracranial pressure \> 20mmhg and refractory to cerebrospinal fluid drainage * pregnancy
randomized trial of exercise and social interaction in a community-based sample of non-demented chinese elders

Conditions: Cognitive Impairment; Dementia; Mild Cognitive Impairment; Alzheimer Disease

Summary: a pilot randomized clinical trial was conducted in a random sample of 120 non-demented chinese elders (ages 60-79) living in a defined community in shanghai, china to compare the effects of interventions (fast walking, tai chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and mri scans. aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions. the long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.

physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. a representative sample of 120 elderly from shanghai, china was randomized to four groups (tai chi, walking, social interaction, no intervention) for 40 weeks. two mri's were obtained, one before the intervention period, the other after. a neuropsychological battery was administered at baseline, 20 weeks and 40 weeks. comparison of changes in brain volumes in intervention groups with the no intervention group were assessed by t-tests. time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.

Eligibility criteria:
inclusion criteria: * living in defined area * either sex * aged 60-79 exclusion criteria: * history of stroke, parkinson's disease or other neurologic disease * inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each * education-adjusted chinese mini-mental examination score \< 26 (to exclude individuals with dementia or moderate cognitive impairment * cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs * contraindications for mri * diagnosis of any illness that would preclude participation in the full study * regular vigorous exercise or tai chi practice.

Keywords: magnetic resonance imaging cognition tai chi physical exercise mental exercise intervention trial prevention dementia alzheimer disease mild cognitive impairment
effect of new posterior reconstruction method on recovery of continence after robot-assisted laparoscopic prostatectomy

Conditions: Localized Prostate Cancer; Urinary Incontinence

Summary: incontinence is one of the most common complications of radical prostatectomy. the continence rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (ralp). however, some reports suggested that posterior reconstruction (pr) behind vesicourethral anastomosis could improve early recovery of continence during open, laparoscopic or robot-assisted radical prostatectomy. but, recent prospective studies reported no benefit of pr after ralp, which was the opposite result of those of previous studies. however the pr techniques used in these prospective studies seem to be quite different from the previous techniques. they seem to have used single-step pr, which opposes the median dorsal fibrous raphe (mdfr) only to the denonvilliers' fascia (df). by contrast, the original technique incorporated additional reconstruction between the mdfr and the posterior bladder wall 1-2 cm from the new bladder neck. our group identified this anatomic structure as the posterior counterpart of the detrusor apron (pda). the pda is a strong, thick functional tissue containing muscle that is more appropriate for pulling and fixing the mdfr than the df. as such, we hypothesized that the key proximal structure for pr is not df, but rather pda. furthermore, single-step reconstruction between mdfr and pda could be enough for pr. we previously investigated whether our new pr technique, which entails opposition of the mdfr solely to the pda, would improve continence recovery compared with the standard ralp technique without pr. and our retrospective study demonstrated that this new pr technique during ralp significantly shortens the time to the recovery of continence compared with the standard technique, which does not incorporate pr (int j urol, 2012;19:683-7). thus, we plan to validate this result by a well-designed, prospective, randomized controlled study.


Eligibility criteria:
inclusion criteria: * pathologically proven localized prostate cancer (≤ct3a) * patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (sang eun lee) exclusion criteria: * prior hormone therapy * prior radiation treatment on prostate or pelvis * preoperative urinary incontinence * refused to participate

Keywords: prostatic neoplasms prostatectomy robotics urinary incontinence